Achieve Life Sciences: Tinanggap ng FDA ang NDA ng cytisinicline; PDUFA Hunyo 20, 2026

Tinanggap ng FDA ang NDA ng cytisinicline para sa pagtigil sa paninigarilyo sa mga nasa hustong gulang. Nagtalaga ang ahensya ng target na petsa ng aksyon ng PDUFA na Hunyo 20, 2026. Sinusuportahan ang NDA ng Phase 3 ORCA-2 at ORCA-3 na datos pati na rin ang pangmatagalang pagkakalantad sa kaligtasan na lumalampas sa mga threshold ng FDA.

Mahahalagang fact

Na-file: Nob 6, 2025, 12:10 PM
Kaganapan: Tinanggap ang aplikasyon
Direksyon: Positibo
Kumpanya: ACHVAchieve Life Sciences
Asset: cytisinicline
Pinagmulan: SEC 8-K
Kumpiyansa: May source
Kalendaryo: Desisyon ng FDA (PDUFA) · Hun 20, 2026 · Complete response letter

Sipi mula sa source

EX-99.1 2 achv-ex99_1.htm EX-99.1 EX-99.1 Exhibit 99.1 Achieve Life Sciences Reports Third Quarter 2025 Financial Results; Provides Updates on Cytisinicline Program One of Only Nine Therapies Chosen for the Inaugural FDA Commissioner’s National Priority Voucher for E-cigarette or Vaping Cessation Conference Call Scheduled for 8:30 AM EST Today, November 6, 2025 SEATTLE and VANCOUVER, British Columbia, November 6, 2025 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (Nasdaq: ACHV), a late-stage specialty pharmaceutical company focused on the global development and commercialization of cytisinicline as a treatment of nicotine dependence, today announced its financial results for third quarter 2025 and confirmed its Prescription Drug User Fee Act (PDUFA) targeted action date of June 20,

SEC 8-K